Stanford APBI Trial

Clinical Trial

Overview

Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.

Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.

Currently, women with breast cancer who undergo a lumpectomy  typically have 6 1/2 weeks of radiation to the entire affected breast after surgery.  Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.

In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.

APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI  worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.

Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:

    Intraoperative Radiotherapy (IORT) - 1 day

    Intracavitary Brachytherapy (MammoSite) - 5 days

    3-D Conformal/External Beam Radiotherapy - 5 days

The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.

Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients

The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • biological: Placebo
  • biological: Abagovomab

Eligibility


Inclusion Criteria:

At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane
intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the
following inclusion criteria:

   - Age >/= 18 years;

   - Properly executed written informed consent;

   - History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IV
   epithelial ovarian, fallopian tube, or primary peritoneal cancer;

   - History of debulking surgery and 6-8 cycles of standard platinum/taxane based
   non-investigational IV-IP chemotherapy;

   - Complete clinical response defined as:

   - Normal physical examination;

   - No symptoms suggestive of persistent cancer;

   - No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis
   within the previous 4 weeks;

   - Negative chest x-ray (or chest CT scan) within the previous 4 weeks;

   - Serum CA125 within the normal laboratory range.

   - Adequate hematologic, renal and hepatic function:

      - Absolute Neutrophil Count (ANC) >/=1.5 * 109/l;

      - Platelets >/= 75 * 109/l;

      - Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl);

      - Serum creatinine
      - Bilirubin
   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Exclusion Criteria:

Patients are ineligible to participate in the study, if any of the following criteria are
present:

   - any other invasive malignancies, with the exception of non-melanoma skin cancer or
   cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment
   contraindicates this protocol therapy;

   - known active autoimmune disease requiring chronic treatment with immunosuppressive
   agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.);

   - known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.);

   - known infection with hepatitis B, or hepatitis C;

   - history of recent myocardial infarction (   (New York Heart Association - NYHA class >/= III);

   - previous or concomitant use of any anti-cancer therapy other than the platinum-taxane
   based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation
   therapy is not permitted after completion of standard front line chemotherapy.

   - concomitant use of any other investigational agent;

   - any prior investigational anti-cancer vaccine or monoclonal antibody;

   - known allergy to murine proteins;

   - any significant medical or psychiatric condition, drug or alcohol abuse that might
   prevent the patient from complying with all study procedures;

   - clinically significant active infection;

   - concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.);

   - major surgery within the previous 2 weeks;

   - radiotherapy within the previous 4 weeks;

   - any significant toxicity from prior chemotherapy;

   - unreliability or inability to follow protocol requirements;

   - potentially childbearing and not willing to use adequate contraceptive methods
   throughout the entire study period;

   - pregnancy.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Fitzsimmons Colleen
6507243155
Not Recruiting

What's New

Stanford’s APBI trial has now been expanded to include women with  ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.